Department of Neurology, Korea University Guro Hospital, Seoul, Korea.
Department of Neurology, Konkuk University School of Medicine, Seoul, Korea.
Acta Neurol Scand. 2020 Feb;141(2):132-140. doi: 10.1111/ane.13197. Epub 2019 Dec 4.
This study aimed to determine the efficacy and safety of perampanel added to monotherapy in patients with focal-onset seizures, with or without secondarily generalized tonic-clonic seizures.
MATERIALS & METHODS: In this multicentre, open-label trial, enrolled patients were treated with perampanel monotherapy. During a 12-week titration period, perampanel was incrementally increased by 2 mg/d over ≥2-week intervals. Patients then entered a 24-week maintenance period. The primary objective was to investigate the 50% responder rate in total seizure frequency, with 75% and 100% responder rates as secondary objectives. Treatment-emergent adverse events (TEAEs) and adverse drug reactions were recorded. A post hoc analysis was performed to investigate the effect of titration speed and different concomitant AEDs on the efficacy and safety of perampanel.
Of the 85 patients analysed, seizure reductions of 50%, 75% and 100% were observed in 80.0% (95% confidence interval [CI]: 69.9-87.9), 71.8% (95% CI: 61.0-81.0) and 47.1% (95% CI: 36.1-58.2) during the maintenance period, respectively. The 50%, 75% and 100% response rates in patients with secondarily generalized tonic-clonic seizures were 87.5% (95% CI: 61.7-98.5), 87.5% (95% CI: 61.7-98.5) and 75.0% (95% CI: 47.6-92.7), respectively. The most common TEAEs were dizziness (50.0%), somnolence (9.8%) and headache (8.8%). The efficacy outcomes and safety profile of perampanel were more favourable with slow titration and relatively consistent when stratified by concomitant AEDs.
Perampanel was effective and well tolerated as a first add-on to monotherapy in patients with focal-onset seizures, with or without secondarily generalized seizures.
本研究旨在确定在伴有或不伴有继发性全面强直-阵挛发作的局灶性发作患者中，添加普瑞巴林作为单药治疗的疗效和安全性。
在这项多中心、开放标签试验中，入组患者接受普瑞巴林单药治疗。在 12 周的滴定期内，普瑞巴林每 2 周增加 2mg/d。然后患者进入 24 周的维持期。主要终点是总发作频率的 50%应答率，75%和 100%应答率为次要终点。记录治疗中出现的不良事件（TEAEs）和药物不良反应。进行事后分析，以研究滴定速度和不同伴随 AEDs 对普瑞巴林疗效和安全性的影响。
在分析的 85 例患者中，维持期分别观察到 50%、75%和 100%的发作减少率，分别为 80.0%（95%置信区间[CI]：69.9-87.9）、71.8%（95% CI：61.0-81.0）和 47.1%（95% CI：36.1-58.2）。伴有继发性全面强直-阵挛发作的患者的 50%、75%和 100%应答率分别为 87.5%（95% CI：61.7-98.5）、87.5%（95% CI：61.7-98.5）和 75.0%（95% CI：47.6-92.7）。最常见的 TEAEs 是头晕（50.0%）、嗜睡（9.8%）和头痛（8.8%）。普瑞巴林的疗效和安全性结果在缓慢滴定时更有利，且按伴随 AEDs 分层时相对一致。
普瑞巴林作为局灶性发作患者的一线附加治疗药物，单药治疗有效且耐受性良好，伴有或不伴有继发性发作。
